Rod, Fixation, Intramedullary and Accessories
Calcaneal Compression Screw, Right, M10 x 10mm
17manufacturers in China registered for this device type
196catalogue numbers in this listing
12510(k) clearances naming this product code
37recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2025-04-14 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 10 to 300 mm |
| Distribution end date | 2024-02-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1896-4020S | Length 20.0 mm | In distribution |
| 1896-4050S | Length 50.0 mm | In distribution |
| 1891-4036S | Diameter: 4.0 Millimeter | In distribution |
| 1891-5090S | Diameter: 5.0 Millimeter | In distribution |
| 1891-4050S | Length 50.0 mm | In distribution |
| 1895-5050S | Length 50.0 mm | In distribution |
| 1796-5105S | Diameter: 5.0 Millimeter | In distribution |
| 1891-5025S | Length 25.0 mm | In distribution |
| 1891-5030S | Length 30.0 mm | In distribution |
| 1891-5095S | Length 95.0 mm | In distribution |
| 1891-4034S | Length 34.0 mm | In distribution |
| 1896-5095S | Length 95.0 mm | In distribution |
| 933-0035 | Length 10.0 mm | In distribution |
| 1891-4060S | Diameter: 4.0 Millimeter | In distribution |
| 1896-5105S | Length 105.0 mm | In distribution |
| 1896-5110S | Diameter: 5.0 Millimeter | In distribution |
| 1896-4040S | Diameter: 4.0 Millimeter | In distribution |
| 1895-5075S | Diameter: 5.0 Millimeter | In distribution |
| 1896-4036S | Length 36.0 mm | In distribution |
| 1891-5105S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5040S | Length 40.0 mm | In distribution |
| 1796-5057S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5030S | Length 30.0 mm | In distribution |
| 1896-5045S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5110S | Length 110.0 mm | In distribution |
| 1796-5037S | Length 37.5 mm | In distribution |
| 622-2011 | Length 200.0 mm | In distribution |
| 1896-5047S | Length 47.5 mm | In distribution |
| 1896-4025S | Length 25.0 mm | In distribution |
| 1896-4045S | Diameter: 4.0 Millimeter | In distribution |
| 1796-5090S | Length 90.0 mm | In distribution |
| 1896-5090S | Length 90.0 mm | In distribution |
| 1896-4022S | Length 22.0 mm | In distribution |
| 1891-5065S | Length 65.0 mm | In distribution |
| 904-0051 | In distribution | |
| 933-0034 | Length 10.0 mm | In distribution |
| 1796-5080S | Diameter: 5.0 Millimeter | In distribution |
| 1891-5085S | Length 85.0 mm | In distribution |
| 1796-5115S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5032S | Length 32.5 mm | In distribution |
| 1896-4038S | Diameter: 4.0 Millimeter | In distribution |
| 1796-5040S | Length 40.0 mm | In distribution |
| 1796-5025S | Length 25.0 mm | In distribution |
| 1896-5025S | Length 25.0 mm | In distribution |
| 1896-5115S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5100S | Diameter: 5.0 Millimeter | In distribution |
| 622-2021 | Length 200.0 mm | In distribution |
| 1891-4045S | Length 45.0 mm | In distribution |
| 1891-5060S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5027S | Length 27.5 mm | In distribution |
| 1895-5045S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5070S | Length 70.0 mm | In distribution |
| 622-2010 | Length 200.0 mm | In distribution |
| 622-3023 | Length 300.0 mm | In distribution |
| 1895-5055S | Length 55.0 mm | In distribution |
| 1891-4055S | Length 55.0 mm | In distribution |
| 1896-5052S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5057S | Length 57.5 mm | In distribution |
| 1895-5040S | Length 40.0 mm | In distribution |
| 1796-5075S | Diameter: 5.0 Millimeter | In distribution |
| 1896-4035S | Length 35.0 mm | In distribution |
| 1796-5042S | Diameter: 5.0 Millimeter | In distribution |
| 1896-4026S | Diameter: 4.0 Millimeter | In distribution |
| 1891-4022S | Diameter: 4.0 Millimeter | In distribution |
| 1796-5052S | Diameter: 5.0 Millimeter | In distribution |
| 1891-4038S | Diameter: 4.0 Millimeter | In distribution |
| 1896-4055S | Length 55.0 mm | In distribution |
| 933-0033 | Length 10.0 mm | In distribution |
| 1891-4024S | Diameter: 4.0 Millimeter | In distribution |
| 1896-4024S | Length 24.0 mm | In distribution |
| 1895-5085S | Length 85.0 mm | In distribution |
| 1896-4028S | Diameter: 4.0 Millimeter | In distribution |
| 1891-4030S | Length 30.0 mm | In distribution |
| 1891-4020S | Diameter: 4.0 Millimeter | In distribution |
| 1896-5042S | Length 42.5 mm | In distribution |
| 1896-5050S | Length 50.0 mm | In distribution |
| 1896-4034S | Diameter: 4.0 Millimeter | In distribution |
| 1796-5100S | Length 100.0 mm | In distribution |
| 1796-5060S | Length 60.0 mm | In distribution |
| 1896-4030S | Length 30.0 mm | In distribution |
| 904-0054 | In distribution | |
| 1895-5095S | Diameter: 5.0 Millimeter | In distribution |
| 622-3011 | Diameter: 11.5 Millimeter | In distribution |
| 1896-5037S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5080S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5085S | Diameter: 5.0 Millimeter | In distribution |
| 622-3021 | Diameter: 11.5 Millimeter | In distribution |
| 622-2023 | Length 200.0 mm | In distribution |
| 622-3013 | Diameter: 13.0 Millimeter | In distribution |
| 1891-4026S | Length 26.0 mm | In distribution |
| 1895-5001S | In distribution | |
| 1891-4032S | Length 32.0 mm | In distribution |
| 1895-5090S | Length 90.0 mm | In distribution |
| 1891-5055S | Length 55.0 mm | In distribution |
| 1796-5045S | Length 45.0 mm | In distribution |
| 904-0052 | In distribution | |
| 1891-5045S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5047S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5075S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5095S | Length 95.0 mm | In distribution |
| 1891-4040S | Diameter: 4.0 Millimeter | In distribution |
| 622-3010 | Length 300.0 mm | In distribution |
| 1891-5050S | Length 50.0 mm | In distribution |
| 1896-5027S | Length 27.5 mm | In distribution |
| 1891-5035S | Diameter: 5.0 Millimeter | In distribution |
| 1895-5115S | Length 115.0 mm | In distribution |
| 1896-5030S | Length 30.0 mm | In distribution |
| 1891-5100S | Diameter: 5.0 Millimeter | In distribution |
| 1891-4025S | Diameter: 4.0 Millimeter | In distribution |
| 1896-5120S | Length 120.0 mm | In distribution |
| 904-0053 | In distribution | |
| 1895-5110S | Diameter: 5.0 Millimeter | In distribution |
| 1895-5120S | Diameter: 5.0 Millimeter | In distribution |
| 1891-5075S | Length 75.0 mm | In distribution |
| 1895-5105S | Length 105.0 mm | In distribution |
| 1896-4032S | Diameter: 4.0 Millimeter | In distribution |
| 1891-4028S | Length 28.0 mm | In distribution |
| 1895-5100S | Length 100.0 mm | In distribution |
| 1896-5060S | Diameter: 5.0 Millimeter | In distribution |
| 1891-5115S | Length 115.0 mm | In distribution |
| 1896-5055S | Diameter: 5.0 Millimeter | In distribution |
| 1891-5080S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5120S | Length 120.0 mm | In distribution |
| 1891-5110S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5035S | Length 35.0 mm | In distribution |
| 622-2020 | Diameter: 10.0 Millimeter | In distribution |
| 1896-4060S | Length 60.0 mm | In distribution |
| 1796-5070S | Length 70.0 mm | In distribution |
| 904-0056 | In distribution | |
| 1796-5055S | Length 55.0 mm | In distribution |
| 1796-5035S | Diameter: 5.0 Millimeter | In distribution |
| 1891-4035S | Diameter: 4.0 Millimeter | In distribution |
| 1891-5040S | Length 40.0 mm | In distribution |
| 1896-5065S | Diameter: 5.0 Millimeter | In distribution |
| 1895-5070S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5032S | Diameter: 5.0 Millimeter | In distribution |
| 1796-5050S | Length 50.0 mm | In distribution |
| 1895-5060S | Length 60.0 mm | In distribution |
| 1891-5070S | Length 70.0 mm | In distribution |
| 1895-5080S | Length 80.0 mm | In distribution |
| 1891-5120S | Diameter: 5.0 Millimeter | In distribution |
| 1895-5065S | Length 65.0 mm | In distribution |
| 1796-5065S | Diameter: 5.0 Millimeter | In distribution |
| 1896-5085S | Length 85.0 mm | In distribution |
| 904-0055 | In distribution | |
| 622-2013 | Length 200.0 mm | In distribution |
| 622-3020 | Length 300.0 mm | In distribution |
| 172-5160 | Length 60.0 mm | Withdrawn |
| 172-6100 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5028 | Length 28.0 mm | Withdrawn |
| 172-6176 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5020 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5166 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5178 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5162 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-6168 | Length 68.0 mm | Withdrawn |
| 172-6195 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5176 | Length 76.0 mm | Withdrawn |
| 172-5164 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5024 | Length 24.0 mm | Withdrawn |
| 172-5150 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-6180 | Length 80.0 mm | Withdrawn |
| 172-5044 | Length 44.0 mm | Withdrawn |
| 172-5032 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5026 | Length 26.0 mm | Withdrawn |
| 172-6172 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5036 | Length 36.0 mm | Withdrawn |
| 172-5148 | Length 48.0 mm | Withdrawn |
| 172-5152 | Length 52.0 mm | Withdrawn |
| 172-6164 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-6160 | Length 60.0 mm | Withdrawn |
| 172-5146 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5168 | Length 68.0 mm | Withdrawn |
| 172-5144 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5154 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-6178 | Length 78.0 mm | Withdrawn |
| 172-5156 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5180 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5030 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5174 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5022 | Length 22.0 mm | Withdrawn |
| 172-5038 | Length 38.0 mm | Withdrawn |
| 172-6174 | Length 74.0 mm | Withdrawn |
| 172-5158 | Length 58.0 mm | Withdrawn |
| 172-6166 | Length 66.0 mm | Withdrawn |
| 172-5170 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-6170 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5042 | Length 42.0 mm | Withdrawn |
| 172-5140 | Length 40.0 mm | Withdrawn |
| 172-6185 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-6162 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5034 | Length 34.0 mm | Withdrawn |
| 172-6190 | Diameter: 6.0 Millimeter | Withdrawn |
| 172-5142 | Diameter: 5.0 Millimeter | Withdrawn |
| 172-5040 | Length 40.0 mm | Withdrawn |
| 172-5172 | Diameter: 5.0 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261481 | 2026-06-29 |
| K253640 | 2026-02-03 |
| K251400 | 2025-08-20 |
| K250163 | 2025-08-13 |
| K230512 | 2023-06-09 |
| K222309 | 2022-11-15 |
| K213328 | 2022-02-11 |
| K203819 | 2021-02-26 |
| K200880 | 2020-07-01 |
| K112059 | 2011-08-08 |
| K915435 | 1992-03-02 |
| K912930 | 1992-01-13 |
Recalls
37 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-05-28 | Class II | Process design | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | ||
| 2025-05-22 | Class II | Under Investigation by firm | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | 1 | |
| 2025-05-22 | Class II | Under Investigation by firm | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | 2 | |
| 2021-05-27 | Class II | Process control | The devices have a different inner diameter than the diameter specified on the outer box label. | 242 | |
| 2021-05-27 | Class II | Process control | The devices have a different inner diameter than the diameter specified on the outer box label. | 52 | |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 186 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 76; OUS 290 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 56 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS 40 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS 400 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 3; OUS 2 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 3; OUS 1 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS: 1404 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 26 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 46; OUS 314 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US:127; OUS 454 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | OUS 121 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | US 3; OUS 13 | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 69 OUS | 2023-09-21 |
| 2020-05-07 | Class II | Process control | Seal integrity of the blister pack may be compromised and sterility cannot be assured | 109 OUS | 2023-09-21 |
| 2018-06-27 | Class II | Packaging process control | Incomplete seal on the Tyvek lid may compromise the sterility of the device | 38 | 2020-04-13 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 17 | 2020-05-21 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2 | 2020-05-21 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 1 | 2020-05-21 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 12 | 2020-05-21 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 7 | 2020-05-21 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 9 | 2020-05-21 |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 | |
| 2018-04-27 | Class II | Employee error | The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage. | 2020-05-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.